Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
90
Countries
1
Sites
12
NSCLC non-small cell lung cancer
to determine ctDNA clearance in TEDOPI plus cemiplimab versus cemiplimab +\- pemetrexed (standard maintenance arm) in patients with HLA-A2 positive NSCLC not progressing after 4 cycles of chemoimmunotherapy.
Key facts
- Sponsor
- Fondazione Ricerca Traslazionale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Jul 2025 → ongoing
- Decision date (initial)
- 2025-04-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Regeneron Ireland Designated Activity Company (DAC) · OSE Immunotherapeutics SA
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
to determine ctDNA clearance in TEDOPI plus cemiplimab versus cemiplimab +\- pemetrexed (standard maintenance arm) in patients with HLA-A2 positive NSCLC not progressing after 4 cycles of chemoimmunotherapy.
Secondary objectives 1
- to evaluate differences in TEDOPI plus cemiplimab versus cemiplimab +\- pemetrexed (standard maintenance arm) in: - Overall Survival - Progression Free Survival - Overall Response Rate (ORR) - Safety - Statistical associations with other biomarkers including PD-L1 and TMB
Conditions and MedDRA coding
NSCLC non-small cell lung cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically or cytologically confirmed diagnosis of non-oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)
- Any patient candidate for first line chemoimmunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures.
Exclusion criteria 7
- Patients not candidate for chemoimmunotherapy
- HLA-A2 negative
- Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated
- Tumor tissue not available (archive or collected before trial inclusion)
- Evidence of EGFR mutations or ALK or ROS1 rearrangements
- Performance status >1 (ECOG)
- Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basaloid)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Differences in ctDNA clearance rate in the two arms of treatment
Secondary endpoints 1
- - Overall Survival - Progression Free Survival according to RECSIT 1:1 - Overall Response Rate (ORR) according to RECSIT 1:1 --- Incidence of any grade Adverse Events measured according to NCI-CTCAE (v. 5.0) Levels of other biomarkers (including PD-L1 and TMB) during the treatments and statistical associations with other outcome measures
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11292393 · Product
- Active substance
- MPS-112
- Other product name
- EP2101, IDM2101
- Pharmaceutical form
- EMULSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 108 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- OSE IMMUNOTHERAPEUTICS
- Paediatric formulation
- No
- Orphan designation
- No
LIBTAYO 350 mg concentrate for solution for infusion.
PRD7478447 · Product
- Active substance
- Cemiplimab
- Substance synonyms
- REGN2810
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 350 mg milligram(s)
- Max total dose
- 12950 mg milligram(s)
- Max treatment duration
- 108 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC33 — -
- Marketing authorisation
- EU/1/19/1376/001
- MA holder
- REGENERON IRELAND D.A.C.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Armisarte 25 mg/ml concentrate for solution for infusion
PRD3649753 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 18500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 108 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/15/1063/001
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Ricerca Traslazionale
- Sponsor organisation
- Fondazione Ricerca Traslazionale
- Address
- Via Dei Santi Quattro 61
- City
- Rome
- Postcode
- 00184
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Ricerca Traslazionale
- Contact name
- Barbara Tomassini
Public contact point
- Organisation
- Fondazione Ricerca Traslazionale
- Contact name
- Barbara Tomassini
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 90 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliera Universitaria Integrata Verona
UOC Oncologia, Piazzale Aristide Stefani 1, 37126, Verona
Fondazione IRCCS San Gerardo Dei Tintori
UOC Centro di Ricerca di Fase 1, Via Giovanni Battista Pergolesi 33, 20900, Monza
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
SSD di Patologia Toracica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Oncologia Medica, Via Santa Sofia 78, 95123, Catania
Centro Di Riferimento Oncologico Di Aviano
SOS Tumori del polmone e della pleura, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Di Perugia
SC Oncologia Medica - Dip. Scienze Onco-Emato-Gastroenterologiche, Piazzale Giorgio Menghini 9, 06129, Perugia
Fondazione IRCCS Policlinico San Matteo
SC Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Istituto Tumori Bari Giovanni Paolo II
SSD Oncologia Medica Toracica, Viale Orazio Flacco 65, 70124, Bari
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Clinica Sperimentale Toraco-Polmonare, Via Mariano Semmola 52, 80131, Naples
IRCCS Ospedale Policlinico San Martino
UO Oncologia Medica 2, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero-Universitaria Maggiore Della Carita
DIMET - SCDU Oncologia, Corso Giuseppe Mazzini 18, 28100, Novara
I.F.O. Istituti Fisioterapici Ospitalieri
Division of Medical Oncology 2, Via Elio Chianesi N 53, 00144, Rome
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2025-07-15 | 2025-10-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519262-42-00 | 1.4 |
| Protocol (for publication) | D1_Protocol_2024-519262-42-00 TC | 1.4 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | na |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF privacy | na |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TTdonation | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TTdonation TC | 1.1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_GPL | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CEMIPLIMAB | na |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC PEMETREXED | na |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519262-42-00_ENG | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519262-42-00_ENG TC | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519262-42-00_ITA | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-519262-42-00_ITA TC | 1.4 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-23 | Italy | Acceptable 2025-04-14
|
2025-04-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-12 | Italy | Acceptable | 2025-07-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-15 | Italy | Acceptable | 2025-07-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-13 | Italy | Acceptable | 2025-08-13 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-24 | Italy | Acceptable | 2026-02-24 |